Effectiveness of Local Anesthetic Infiltration with Articaine 4% in Comparison to Inferior Alveolar Nerve Block with Lidocaine 2% for Mandibular 1st Molar Extraction
To compare the efficacy of a local anaesthetic infiltration of 4% articaine versus a regional block technique using 2% lidocaine on patients who need to have their first lower molar removed.
Design
controlled, parallel-group clinical trial
Settings and conduct
Patients are blinded
Participants/Inclusion and exclusion criteria
Patients eligible for mandibular 1st. molar extraction
with no systemic, chronic, metabolic, or infectious disease
Intervention groups
Patients who need their Mandibular first Molar to be removed under local anaesthesia. The first group will receive 1.8 ml of 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration injection.
Main outcome variables
After extracting a non-restorable Mandibular first Molar, pain will be measured para-operatively using a verbal rating scale.
General information
Reason for update
Acronym
LATE
IRCT registration information
IRCT registration number:IRCT20241220064111N1
Registration date:2025-01-11, 1403/10/22
Registration timing:retrospective
Last update:2025-01-11, 1403/10/22
Update count:0
Registration date
2025-01-11, 1403/10/22
Registrant information
Name
Sinan Shwailiya
Name of organization / entity
University of Babylon
Country
Iraq
Phone
+964 781 565 8001
Email address
dent.sinan.a.shwailiya@uobabylon.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-01, 1403/08/11
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
2024-11-01, 1403/08/11
Actual recruitment end date
2024-11-30, 1403/09/10
Trial completion date
2024-12-01, 1403/09/11
Scientific title
Effectiveness of Local Anesthetic Infiltration with Articaine 4% in Comparison to Inferior Alveolar Nerve Block with Lidocaine 2% for Mandibular 1st Molar Extraction
Public title
Local Anesthesia for Tooth Extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subject with no systemic disease
Subject diagnosed for extraction of lower 1st. Molar
Exclusion criteria:
Patients with chronic Cardio-vascular disease
Patients with infectious diseases
Patients allergic to local anesthetic drug
Pregnant ladies
Age
From 18 years old to 63 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
When patients are diagnosed to be indicated for removal of non-restorable lower 1st. molar, they are allocated sequentially and arbitrarily to be included in either intervention groups one by one.
Blinding (investigator's opinion)
Single blinded
Blinding description
patients are not aware of the techniques used in the study
Placebo
Not used
Assignment
Parallel
Other design features
none
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee/Department of Oral and Maxillofacial surgery/College of Dentistry/Universi
Street address
no.3, Al-Jamiea st.
City
Hilla
Postal code
00964
Approval date
2024-10-06, 1403/07/15
Ethics committee reference number
6876/2024
Health conditions studied
1
Description of health condition studied
Dental Caries, Tooth Fracture, destructive and non-restorable Mandibular 1st. Molar
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Local anesthetic technique
Timepoint
5 minutes
Method of measurement
patient description
Secondary outcomes
empty
Intervention groups
1
Description
The first group will receive a buccal and lingual infiltration injection of 1.8 ml of 4% articaine + 1:100,000 epinephrine local anesthetic pre-operatively using a dental syringe.
Category
Treatment - Drugs
2
Description
The second group will receive a conventional inferior alveolar nerve block technique (regional anesthesia) of 2% lidocaine + epinephrine (1:80,000) local anesthetic drug for tooth extraction, using an amount of 1.8 ml, pre-operatively using a dental syringe.